Effects of Amlodipine in the Management of Chronic Heart Failure

This study has suspended participant recruitment.
Sponsor:
Information provided by:
Rennes University Hospital
ClinicalTrials.gov Identifier:
NCT00151619
First received: September 8, 2005
Last updated: December 30, 2005
Last verified: December 2005

September 8, 2005
December 30, 2005
February 1999
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Humeral blood flow
Same as current
Complete list of historical versions of study NCT00151619 on ClinicalTrials.gov Archive Site
  • Systemic hemodynamics:
  • - Systolic and diastolic arterial pressures
  • - Heart rate and cardiac output
  • - Systolic and diastolic left ventricular diameters
  • - Ambulatory measure of arterial pressure
  • - Isovolumic relaxation time, pulmonary venous flow
  • Regional hemodynamics:
  • - Carotid, humeral and femoral arterial diameters and flows
  • - Arterial compliance
  • - Renal and hepatosplanchnic blood flow
  • Stress test
  • Biological variables: ionogram, hormonal and cytokines plasma concentrations
  • Functional well-being measure on a Visual Analogue Scale.
Same as current
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Effects of Amlodipine in the Management of Chronic Heart Failure
Regional and Systemic Hemodynamic Effects of a Long-Term Administration of Amlodipine in Patients With Chronic Heart Failure Treated With a Combination of Enalapril, Furosemide and Digoxin

Patients with congestive heart failure are usually treated with a combination of an ACE inhibitor (or an AT1 blocking agent), a diuretic and a beta-blocker. However, some patients remain symptomatic despite an optimal treatment with these drugs. In patients who also have coronary heart disease, nitrates or some calcium-channel blockers could help to relieve symptoms. Therefore, the aim of our study is to evaluate the additional benefit induced by a second generation calcium-channel blocker, amlodipine, in patients with chronic heart failure who remain symptomatic despite an optimal treatment.

In patients with congestive heart failure, a treatment with ACE inhibitor combined with digoxin and a diuretic has shown benefits on morbidity and mortality. However, 40% of these patients have persistant symptoms. The rationale for the use of calcium channel blockers in patients with chronic heart failure lies in their vasodilating action, antiischemic effect, ability to reduce left ventricular diastolic dysfunction. The objective of our study is to evaluate the regional and systemic hemodynamic, hormonal and vascular effects and the tolerance to stress test of a 3-months treatment with amlodipine. Patients with stable chronic heart failure (III/IV NYHA) and treated with a combination of enalapril, furosemide and digoxin will be randomized to receive amlodipine 5 or 10 mg or a placebo for a 3-months period.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Chronic Heart Failure
Drug: Amlodipine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
24
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Inclusion Criteria:

  • Patients over 18 years
  • Chronic heart failure with New York Heart Association class III or IV.
  • Ischemic or dilated cardiopathy known for at least 3 months
  • Systolic arterial pressure > 110 mmHg under treatment
  • Stroke volume between 20 and 40% under treatment
  • Informed written consent

Exclusion Criteria:

  • History of allergy to one of the studied pharmaceutical classes
  • History of troubles in ventricular rythm (tachycardia, fibrillation) or acute heart failure
  • Chronic renal, hepatic or respiratory failure
  • Diabetes
  • Valvulopathy
  • Myocarditis,constrictive pericarditis
  • Life prognosis < 6 months due to a non cardiac pathology
  • Absence of woman contraception, pregnancy, breast-feeding
  • Treatment with calcium channel blockers or antiarrythmics class IC
  • Unstable patient under standardized treatment
  • Unable to do a stress test
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00151619
AFSSAPS 960723, LOC-H/95-02, CIC0203/005
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Not Provided
Rennes University Hospital
Not Provided
Principal Investigator: Eric Bellissant, MD, PhD CHU Rennes
Rennes University Hospital
December 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP